Analytical performance evaluation of the Elecsys® Troponin T Gen 5 STAT assay.
Publication/Presentation Date
8-1-2019
Abstract
BACKGROUND: We report the analytical performance of the Elecsys® Troponin T Gen 5 STAT (TnT Gen 5 STAT; Roche Diagnostics) assay.
METHODS: Measuring limits/ranges were determined in lithium-heparin plasma samples per Clinical and Laboratory Standards Institute (CLSI) EP17-A2. Precision was evaluated per CLSI EP05-A2 using lithium-heparin plasma/quality control samples on cobas e 411/cobas e 601 analyzers; two duplicated runs per day for 21 days (n = 84). Cross-reactivity with other troponin forms and interference from endogenous substances/drugs was tested; recovery criterion for no cross-reactivity was within ±10%.
RESULTS: Coefficients of variation (CV) for repeatability/intermediate precision were 0.7-5.6%/1.4-10.3% (cobas e 411; mean cardiac troponin T [cTnT]: 7.3-9341 ng/L) and 0.7-3.0%/1.5-6.4% (cobas e 601; mean cTnT: 7.4-9455 ng/L). There was no cross-reactivity with skeletal muscle troponin T (≤ 10,000 ng/L), skeletal muscle troponin I (≤ 100,000 ng/L), cardiac troponin I (≤ 10,000 ng/L), or human troponin C (≤ 80,000 ng/L). No interference was observed with biotin (≤ 20 ng/mL) or 34 drugs.
CONCLUSION: The TnT Gen 5 STAT assay demonstrated a CV of < 10% at the 99th percentile upper reference limit, meeting precision requirements (Fourth Universal Definition of Myocardial Infarction) for high-sensitivity troponin assays.
Volume
495
First Page
522
Last Page
528
ISSN
1873-3492
Published In/Presented At
Fitzgerald, R. L., Hollander, J. E., Peacock, W. F., Limkakeng, A. T., Breitenbeck, N., Blechschmidt, K., Laimighofer, M., & deFilippi, C. (2019). Analytical performance evaluation of the Elecsys® Troponin T Gen 5 STAT assay. Clinica chimica acta; international journal of clinical chemistry, 495, 522–528. https://doi.org/10.1016/j.cca.2019.05.026
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
31152695
Department(s)
Administration and Leadership
Document Type
Article